Early Prediction of Hypocalcaemia Following Thyroid Surgery

University of Cagliari

Status: Completed

Conditions: Hypocalcemia

Treatments: Other: iPTH; Other: no dosage of iPTH

Study type: Interventional

Funder types: Other

Identifiers

NCT02853721

PG/2014/9514

Details and patient eligibility

About

150 patients divided into two groups.The experimental group was submitted at the assay of iPTH six hours after surgery whilst the control group was submitted to a daily assay of serum calcium and phosphorus.

Full description

Purpose: The aim of this randomized controlled trial was to validate the results of a previous prospective cohort study conducted in the same surgical unit regarding the use of concomitant intact parathyroid hormone (iPTH) and serum calcium measurement in predicting hypocalcemia after total thyroidectomy.

Methods: From January 2014 to January 2015, 150 patients underwent total thyroidectomy in our department and were divided into two groups. The experimental group was submitted at the assay of iPTH six hours after surgery whilst the control group was submitted to a daily assay of serum calcium and phosphorus. Sensitivity and specificity of different serum measurements have been calculated using the Receiver-operator characteristics (ROC) curve.

Enrollment: 150 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be submitted to total thyroidectomy during the study period
• Have signed the informed consent

Exclusion criteria

• Lack of inclusion criteria
• Lobectomy with isthmusectomy or partial or subtotal thyroidectomy
• Completion thyroidectomy
• Concomitant hyperparathyroidism was present
• Concomitant treatment with oral calcium and/or vitamin D prior to surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Experimental group

Experimental group

Description:

iPTH at 6 hours after surgery

Treatment:

Other: iPTH

Control group

Other group

Description:

no dosage of iPTH

Treatment:

Other: no dosage of iPTH